Spinal Cord NeoplasmsNCT02494622
Alternative Treatment of Giant Spinal Schwannomas
An observational study of Spinal Cord Neoplasms, run by Gulsah Karaoren at 1 site in Turkey (Türkiye).
Trial summary
Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of these cases differ from those of small schwannomas. The aim of this study was to review the diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of patients who underwent surgery. Read more about this study
- Who is it for?
- Ages 16 to 76 years
- Conditions the study is for
- Spinal Cord Neoplasms
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients, who underwent surgery for benign spinal schwannoma Sridhar Type III, IV and V (all tumors were larger than 2.5 cm).
Who may be able to join
- Patients diagnosed with benign spinal schwannoma Sridhar Type III, IV and V
Who cannot join
- Malign spinal schwannoma
- Sridhar Type I and II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alternatives to The Surgical Approach for Giant Spinal Schwannomas: A Clinic Trial
Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of these cases differ from those of small schwannomas. The aim of this study was to review the diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of patients who underwent surgery.
- Conditions
- Spinal Cord Neoplasms
- Medical subject headings
- Spinal Cord Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the alternative surgical techniques to the amount of the tumor mass which measured by Nurick Scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsah Karaoren
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Said Naderi, Proffesor, Study chair, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494622
- Sponsor's protocol ID
- GK8
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Samii M, Alimohamadi M, Gerganov V. Surgical Treatment of Jugular Foramen Schwannoma: Surgical Treatment Based on a New Classification. Neurosurgery. 2015 Sep;77(3):424-32; discussion 432. doi: 10.1227/NEU.0000000000000831.
PubMed 26075309Ohnishi Y, Iwatsuki K, Ohkawa T, Ninomiya K, Moriwaki T, Yoshimine T. Differences between Cervical Schwannomas of the Anterior and Posterior Nerve Roots in Relation to the Incidence of Postoperative Radicular Dysfunction. Asian Spine J. 2015 Apr;9(2):263-70. doi: 10.4184/asj.2015.9.2.263. Epub 2015 Apr 15.
PubMed 25901239
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternatives to The Surgical Approach for Giant Spinal Schwannomas: A Clinic Trial
- ClinicalTrials.gov ID
- NCT02494622
- Acronym / sponsor ID
- GK8
- Conditions
- Spinal Cord Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gulsah KaraorenOther government
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of these cases differ from those of small schwannomas. The aim of this study was to review the diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of patients who underwent surgery.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients, who underwent surgery for benign spinal schwannoma Sridhar Type III, IV and V (all tumors were larger than 2.5 cm).
Key inclusion criteria (1 listed)
- Patients diagnosed with benign spinal schwannoma Sridhar Type III, IV and V
Key exclusion criteria (2 listed)
- Malign spinal schwannoma
- Sridhar Type I and II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of the alternative surgical techniques to the amount of the tumor mass which measured by Nurick Scale
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
- Background: PubMed 26075309Samii M, Alimohamadi M, Gerganov V. Surgical Treatment of Jugular Foramen Schwannoma: Surgical Treatment Based on a New Classification. Neurosurgery. 2015 Sep;77(3):424-32; discussion 432. doi: 10.1227/NEU.0000000000000831.
- Background: PubMed 25901239Ohnishi Y, Iwatsuki K, Ohkawa T, Ninomiya K, Moriwaki T, Yoshimine T. Differences between Cervical Schwannomas of the Anterior and Posterior Nerve Roots in Relation to the Incidence of Postoperative Radicular Dysfunction. Asian Spine J. 2015 Apr;9(2):263-70. doi: 10.4184/asj.2015.9.2.263. Epub 2015 Apr 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Said Naderi, Proffesor study chair
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Neoplasms, run by Gulsah Karaoren at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of the alternative surgical techniques to the amount of the tumor mass which measured by Nurick Scale (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494622, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.